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Metoclopramide and Ketoprofen in Acute Migraine of Child
NCT00557544Phase 3
Key facts
- Status
- Withdrawn
- Start
- Jun 2009
- Primary completion
- Dec 2009
- Countries
- 1
- Sponsor
- IRCCS Burlo Garofolo
- Modality
- Small Molecules
- Conditions
- migraine
01
Overview
Phase 3, randomised, double-blind trial in migraine comparing Metoclopramide + Ketoprofen, Metoclopramide + Placebo and Ketoprofen + Placebo (3 arms). Primary endpoint: Evaluation of healing times from pain at 2 hours. Planned start Jun 2009; status: withdrawn.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Metoclopramide + Ketoprofen
Metoclopramide 0.15 mg/kg + Ketoprofen 1 mg/kg
Metoclopramide + Placebo
Metoclopramide 0.15 mg/kg + Placebo
Ketoprofen + Placebo
Ketoprofen 1 mg/kg + Placebo
03
Who it enrols
Children 6-17 years old with migraine presenting in emergency room, excluding those with hemiplegic migraine or those who have already treated the current migraine attack.
04
Endpoints
Primary
Evaluation of healing times from pain
Secondary
Percentage of healing from acute migraine
Percentage of relapses of pain
Need of a rescue drug
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